The Mycophenolate Pregnancy Registry

About the trial

Sponsor

Genentech, Inc. (with Accord Healthcare, Inc., Alkem Laboratories Ltd, Ascend Laboratories, LLC, Amneal Pharmaceuticals, LLC, Amta labs Limited, Apotex Inc., Avet Lifesciences Limited, Azurity Pharmaceuticals, Biocon Pharma Limited, Concord Biotech Limited, Endo USA Inc., a Keenova Therapeutics Company, Hetero Labs Limited, Unit-V, Hikma Pharmaceuticals USA Inc., Hisun Pharmaceuticals, Jubilant Cadista Pharmaceuticals, Inc., Lannett Company, Inc., Meitheal Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc, Novartis Pharmaceuticals, Rising Pharma Holdings, Inc., RK Pharma Inc., Sandoz, Strides Pharma, Inc, Teva Pharmaceuticals USA, TWi Pharmaceuticals, Inc., VistaPharm, Inc., Wuxi Fortune Pharmaceutical Co., Ltd, Zydus Pharmaceuticals)

Dates

Started 2012-11-20; completion 2026-08-27

Results posted

Not yet

The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified. This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulati…

From ClinicalTrials.gov, last updated 2026-10-13. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Mylan Inc. reported $2,025 in research payments for this study in 2025 (4 payments).

Products named: Mycophenolate Mofetil

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.